Dataset Information

Stepped Exercise Program for Patients With Knee Osteoarthritis : A Randomized Controlled Trial.

ABSTRACT:

Background

Evidence-based models are needed to deliver exercise-related services for knee osteoarthritis efficiently and according to patient needs.

Objective

To examine a stepped exercise program for patients with knee osteoarthritis (STEP-KOA).

Design

Randomized controlled trial. (ClinicalTrials.gov: NCT02653768).

Setting

2 U.S. Department of Veterans Affairs sites.

Participants

345 patients (mean age, 60 years; 15% female; 67% people of color) with symptomatic knee osteoarthritis.

Intervention

Participants were randomly assigned in a 2:1 ratio to STEP-KOA or an arthritis education (AE) control group, respectively. The STEP-KOA intervention began with 3 months of an internet-based exercise program (step 1). Participants who did not meet response criteria for improvement in pain and function after step 1 progressed to step 2, which involved 3 months of biweekly physical activity coaching calls. Participants who did not meet response criteria after step 2 went on to in-person physical therapy visits (step 3). The AE group received educational materials via mail every 2 weeks.

Measurements

Primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Scores for the STEP-KOA and AE groups at 9 months were compared by using linear mixed models.

Results

In the STEP-KOA group, 65% of participants (150 of 230) progressed to step 2 and 35% (81 of 230) to step 3. The estimated baseline WOMAC score for the full sample was 47.5 (95% CI, 45.7 to 49.2). At 9-month follow-up, the estimated mean WOMAC score was 6.8 points (CI, -10.5 to -3.2 points) lower in the STEP-KOA than the AE group, indicating greater improvement.

Limitation

Participants were mostly male veterans, and follow-up was limited.

Conclusion

Veterans in STEP-KOA reported modest improvements in knee osteoarthritis symptoms compared with the control group. The STEP-KOA strategy may be efficient for delivering exercise therapies for knee osteoarthritis.

Primary funding source

Department of Veterans Affairs, Health Services Research and Development Service.

SUBMITTER: Allen KD

PROVIDER: S-EPMC10405203 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Stepped Exercise Program for Patients With Knee Osteoarthritis : A Randomized Controlled Trial.

Allen Kelli D KD Woolson Sandra S Hoenig Helen M HM Bongiorni Dennis D Byrd James J Caves Kevin K Hall Katherine S KS Heiderscheit Bryan B Hodges Nancy Jo NJ Huffman Kim M KM Morey Miriam C MC Ramasunder Shalini S Severson Herbert H Van Houtven Courtney C Abbate Lauren M LM Coffman Cynthia J CJ

Annals of internal medicine 20201229 3

<h4>Background</h4>Evidence-based models are needed to deliver exercise-related services for knee osteoarthritis efficiently and according to patient needs<b>.</b><h4>Objective</h4>To examine a stepped exercise program for patients with knee osteoarthritis (STEP-KOA).<h4>Design</h4>Randomized controlled trial. (ClinicalTrials.gov: NCT02653768).<h4>Setting</h4>2 U.S. Department of Veterans Affairs sites.<h4>Participants</h4>345 patients (mean age, 60 years; 15% female; 67% people of color) with s ...[more]

PMID: 33370174

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Project description:BackgroundPhysical therapy (PT) and other exercise-based interventions are core components of care for knee osteoarthritis (OA), but both are underutilized, and some patients have limited access to PT services. This clinical trial is examining a STepped Exercise Program for patients with Knee OsteoArthritis (STEP-KOA). This model of care can help to tailor exercise-based interventions to patient needs and also conserve higher resource services (such as PT) for patients who do not make clinically relevant improvements after receiving less costly interventions.Methods / designStep-KOA is a randomized trial of 345 patients with symptomatic knee OA from two Department of Veterans Affairs sites. Participants are randomized to STEP-KOA and Arthritis Education (AE) Control groups with a 2:1 ratio, respectively. STEP-KOA begins with 3 months of access to an internet-based exercise program (Step 1). Participants not meeting response criteria for clinically meaningful improvement in pain and function after Step 1 progress to Step 2, which involves bi-weekly physical activity coaching calls for 3 months. Participants not meeting response criteria after Step 2 progress to in-person PT visits (Step 3). Outcomes will be assessed at baseline, 3, 6 and 9 months (primary outcome time point). The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), and secondary outcomes are objective measures of physical function. Linear mixed models will compare outcomes between the STEP-KOA and AE control groups at follow-up. We will also evaluate patient characteristics associated with treatment response and conduct a cost-effectiveness analysis of STEP-KOA.DiscussionSTEP-KOA is a novel, efficient and patient-centered approach to delivering exercise-based interventions to patients with knee OA, one of the most prevalent and disabling health conditions. This trial will provide information on the effectiveness of STEP-KOA as a novel potential model of care for treatment of OA.Trial registrationClinicaltrials.gov, NCT02653768 (STepped Exercise Program for Knee OsteoArthritis (STEP-KOA)), Registered January 12, 2016.

Project description:ObjectiveCertain exercises could overload the osteoarthritic knee. We developed an exercise program from yoga postures with a minimal knee adduction moment for knee osteoarthritis. The purpose was to compare the effectiveness of this biomechanically-based yoga exercise (YE), with traditional exercise (TE), and a no-exercise attention-equivalent control (NE) for improving pain, self-reported physical function and mobility performance in women with knee osteoarthritis.DesignSingle-blind, three-arm randomized controlled trial.SettingCommunity in Southwestern Ontario, Canada.ParticipantsA convenience sample of 31 women with symptomatic knee osteoarthritis was recruited through rheumatology, orthopaedic and physiotherapy clinics, newspapers and word-of-mouth.InterventionsParticipants were stratified by disease severity and randomly allocated to one of three 12-week, supervised interventions. YE included biomechanically-based yoga exercises; TE included traditional leg strengthening on machines; and NE included meditation with no exercise. Participants were asked to attend three 1-hour group classes/sessions each week.MeasurementsPrimary outcomes were pain, self-reported physical function and mobility performance. Secondary outcomes were knee strength, depression, and health-related quality of life. All were assessed by a blinded assessor at baseline and immediately following the intervention.ResultsThe YE group demonstrated greater improvements in KOOS pain (mean difference of 22.9 [95% CI, 6.9 to 38.8; p = 0.003]), intermittent pain (mean difference of -19.6 [95% CI, -34.8 to -4.4; p = 0.009]) and self-reported physical function (mean difference of 17.2 [95% CI, 5.2 to 29.2; p = 0.003]) compared to NE. Improvements in these outcomes were similar between YE and TE. However, TE demonstrated a greater improvement in knee flexor strength compared to YE (mean difference of 0.1 [95% CI, 0.1 to 0.2]. Improvements from baseline to follow-up were present in quality of life score for YE and knee flexor strength for TE, while both also demonstrated improvements in mobility. No improvement in any outcome was present in NE.ConclusionsThe biomechanically-based yoga exercise program produced clinically meaningful improvements in pain, self-reported physical function and mobility in women with clinical knee OA compared to no exercise. While not statistically significant, improvements in these outcomes were larger than those elicited from the traditional exercise-based program. Though this may suggest that the yoga program may be more efficacious for knee OA, future research studying a larger sample is required.Trial registrationClinicalTrials.gov (NCT02370667).

Project description:BackgroundExercise therapy is recommended by international guidelines as a core treatment for patients with knee osteoarthritis. However, there is a significant gap between recommendations and practice in health care. Digital exercise apps are promising to help solve this undersupply.ObjectiveThis study aims to evaluate the efficacy of a 12-week fully automated app-based exercise intervention with and without a supporting knee brace on health-related outcomes, performance measures, and adherence in patients with knee osteoarthritis.MethodsThis closed user group trial included participants with moderate to severe unicondylar painful knee osteoarthritis. Randomization was 1:1:2 into an intervention group (IG) with 2 subgroups (app-based training [IG A] and app-based training and a supportive knee brace [IG AB]) and a control group (CG). The intervention included a 12-week home exercise program with 3 sessions per week. Instructions for the exercises were given via the app and monitored using 2 accelerometers placed below and above the affected knee joint. Participants in the CG did not receive any study intervention but were allowed to make use of usual care. Osteoarthritis-specific pain (Knee Injury and Osteoarthritis Outcome Score) was defined as the primary outcome, and secondary outcomes included all other Knee Injury and Osteoarthritis Outcome Score subscales, general health-related quality of life (Veterans RAND 12-item Health Survey), psychological measures (eg, exercise self-efficacy), performance measures (strength and postural control), and the monitoring of adherence and safety. Outcomes were assessed at baseline and after 12 weeks. Intervention effects were calculated using baseline-adjusted analysis of covariance for the joint comparison of IG A and IG AB versus the CG using a per-protocol approach. Subgroup analyses were conducted for each IG separately.ResultsA total of 61 participants were included (IG: n=30, 49%; CG: n=31, 51%; male: n=31, 51%; female: n=30, 49%; mean age 62.9, SD 8.5 years; mean BMI 27.7, SD 4.5 kg/m2). Analysis revealed statistically significant effects in favor of the IG for pain reduction (P<.001; effect size [ES]=0.76), improvements in physical function (P<.001; ES=0.64), improvements in symptoms (P=.01; ES=0.53), improvements in sport and recreation activities (P=.02; ES=0.47), improvements in knee-related quality of life (P<.001; ES=0.76), and improvements in the physical component of general health-related quality of life (P<.001; ES=0.74). Mean differences ranged from 6.0 to 13.2 points (scale range 0-100). ESs indicated small to medium effects. No effects were found for psychological and performance measures. Participants adhered to 92.5% (899/972) of all scheduled exercise sessions.ConclusionsIndividuals with knee osteoarthritis undergoing a 12-week sensor-assisted app-based exercise intervention with or without an additional knee brace experienced clinically meaningful treatment effects regarding pain relief and improvements in physical function as well as other osteoarthritis-specific concerns compared to controls.Trial registrationGerman Clinical Trials Register (DRKS) DRKS00023269; https://drks.de/search/de/trial/DRKS00023269.

Project description:BACKGROUND:It is not yet clear which of the various electrophysical modalities used in clinical practice is the one that contributes most positively when added to an exercise program in patients with knee osteoarthritis (OA). The aim of the present study was to analyze the clinical effects of the inclusion of interferential current therapy (ICT), shortwave diathermy therapy (SDT) and photobiomodulation (PHOTO) into an exercise program in patients with knee OA. METHODS:This prospective, five-arm, randomised, placebo-controlled trial was carried out with blinded participants and examiners. We recruited 100 volunteers aged 40 to 80?years with knee OA. Participants were allocated into five groups: exercise, exercise + placebo, exercise + ICT, exercise + SDT, and exercise + PHOTO. The outcome measures included Western Ontario and McMaster Universities (WOMAC), numerical rating pain scale (NRPS), pressure pain threshold (PPT), self-perceived fatigue and sit-to-stand test (STST), which were evaluated before and after 24 treatment sessions at a frequency of three sessions per week. RESULTS:In all groups, there was a significant improvement (p?<?0.05) in all variables over time, except pressure pain threshold. We observed significant differences (p?<?0.05) between the groups for WOMAC function (exercise vs. exercise + placebo, mean difference [MD]?=?5.55, 95% confidence interval [CI]?=?3.63 to 7.46; exercise vs. exercise + ICT, MD?=?3.40, 95% CI?=?1.46 to 5.33; exercise vs. exercise + SDT, MD?=?4.75, 95% CI?=?1.85 to 7.64; exercise vs. exercise + PHOTO, MD?=?5.45, 95% CI?=?3.12 to 7.77) and WOMAC pain, with better scores achieved by the exercise group. However, these differences were not clinically relevant when considering the minimum clinically important difference. CONCLUSION:The addition of ICT, SDT or PHOTO into an exercise program for individuals with knee OA is not superior to exercise performed in isolation in terms of clinical benefit. clinicaltrials.gov: NCT02636764, registered on March 29, 2014.

Project description:BackgroundKnee trauma permanently elevates one's risk for knee osteoarthritis. Despite this, people at-risk of post-traumatic knee osteoarthritis rarely seek or receive care, and accessible and efficacious interventions to promote knee health after injury are lacking. Exercise can ameliorate some mechanisms and independent risk factors for osteoarthritis and, education and action-planning improve adherence to exercise and promote healthy behaviours.MethodsTo assess the efficacy of a virtually-delivered, physiotherapist-guided exercise-based program (SOAR) to improve knee health in persons discharged from care after an activity-related knee injury, 70 people (16-35 years of age, 12-48 months post-injury) in Vancouver Canada will be recruited for a two-arm step-wedged assessor-blinded delayed-control randomized trial. Participants will be randomly allocated to receive the intervention immediately or after a 10-week delay. The program consists of 1) one-time Knee Camp (group education, 1:1 individualized exercise and activity goal-setting); 2) weekly individualized home-based exercise and activity program with tracking, and; 3) weekly 1:1 physiotherapy-guided action-planning with optional group exercise class. Outcomes will be measured at baseline, 9- (primary endpoint), and 18-weeks. The primary outcome is 9-week change in knee extension strength (normalized peak concentric torque; isokinetic dynamometer). Secondary outcomes include 9-week change in moderate-to-vigorous physical activity (accelerometer) and self-reported knee-related quality-of-life (Knee injury and OA Outcome Score subscale) and self-efficacy (Knee Self Efficacy Scale). Exploratory outcomes include 18-week change in primary and secondary outcomes, and 9- and 18- week change in other components of knee extensor and flexor muscle function, hop function, and self-reported symptoms, function, physical activity, social support, perceived self-care and kinesiophobia. Secondary study objectives will assess the feasibility of a future hybrid effectiveness-implementation trial protocol, determine the optimal intervention length, and explore stakeholder experiences.DiscussionThis study will assess the efficacy of a novel, virtually-delivered, physiotherapist-guided exercise-based program to optimize knee health in persons at increased risk of osteoarthritis due to a past knee injury. Findings will provide valuable information to inform the management of osteoarthritis risk after knee trauma and the conduct of a future effectiveness-implementation trial.Trial registrationClinicaltrials.gov reference: NTC04956393. Registered August 5, 2021, https://clinicaltrials.gov/ct2/show/NCT04956393?term=SOAR&cond=osteoarthritis&cntry=CA&city=Vancouver&draw=2&rank=1.

Dataset Information

Stepped Exercise Program for Patients With Knee Osteoarthritis : A Randomized Controlled Trial.

Background

Objective

Design

Setting

Participants

Intervention

Measurements

Results

Limitation

Conclusion

Primary funding source

Publications

Stepped Exercise Program for Patients With Knee Osteoarthritis : A Randomized Controlled Trial.

Similar Datasets

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